System and method for the collection of observations

ABSTRACT

A system for the collection of observations is described which has particular application in the clinical research and aerospace industries. The system has a planning station, for preparing a work package of observations to be collected; a download station, for downloading the work package to at least one primary capture tool, the primary capture tool being used to collect observations according to the work package autonomously; and an upload station, for uploading the observations from the at least one primary capture tool. The invention also concerns a method for collecting observations, as well as a graphical interface therefor. The invention makes use of an atomic database, which obviates the need to reprogram the database when it is to be used for a different set of observations to be collected.

RELATED APPLICATION

The present application is a Continuation-in-part of U.S. patentapplication Ser. No. 09/874,860 filed on Jun. 5, 2001, itself claimingpriority from U.S. provisional application Ser. No. 60/210,471 filed onJun. 9, 2000.

FIELD OF THE INVENTION

The present invention relates to a system and a method for thecollection of observations by a plurality of users. The presentinvention finds particular use in the pharmaceutical research andaircraft maintenance environments, where observations must be rigorouslycollected, tabulated and analysed.

DESCRIPTION OF THE PRIOR ART

The field of data collection based on observation is one where theaccuracy of measurements is critical. As an example, such observationsare necessary for conducting research in new drugs or therapies. In sucha case, a drug or treatment is administered to a subject. At regularintervals, a person, the observer, observes the subject and notes anyobservations. These observations are then collected and analysed inorder to evaluate the efficiency, side effects, etc. of the drug ortreatment.

Presently, these observations are typically recorded on a piece of paperby the observer. They are subsequently entered on a computer system byan operator, which introduces a degree of error. Such a process is alsoextremely time consuming.

As another example, in an unrelated field, aircrafts are routinelyinspected prior to take-off in order to ensure airworthiness. Theseinspections are performed using a checklist, generally on a piece ofpaper, which also introduces a degree of error.

In both examples cited above the observation collecting process isalmost entirely dependant on the observer's competency and thoroughness;there is no mechanism to ensure that the observations are exact andcollected in the proper manner. This uncertainty may have direconsequences, especially in cases such as aircraft inspection wherelives literally depend on the collected observations.

Although some attempts have been made in order to automate the gatheringof observations in both the clinical and aerospace industries, none ofthe solutions proposed have met with commercial success.

Automated data observation collection systems are also known in otherfields such as the creation and maintenance of geographic databases.Examples of such systems are for example taught by U.S. Pat. Nos.5,731,997 (MANSON et al.) and U.S. Pat. No. 6,343,301 (HALT et al.). Onedrawback of the systems disclosed in both these patents is the fact thatthey are application specific; it would be impossible to adapt them fora different application without completely transforming its software andpossibly hardware so as to render them completely unrecognizable fromtheir original form.

There is therefore a need for a system and a method for the collectionof observations which alleviates the above-mentioned drawbacks.

SUMMARY OF THE INVENTION

It is an object of the invention to provide a system and method for thecollection of observations which is portable, easy to handle and morereliable than the prior systems.

In accordance with the invention, this object is achieved with a systemfor a collection of observations by a plurality of users. This systemincludes:

-   -   a planning station for preparing work packages of observations        to be collected by the users, each work package being tailored        to a user profile of a corresponding user;    -   a plurality of primary capture tools each associated with one of        the users, each of these primary capture tools being adapted to        be used to collect observations according to one of the work        packages;    -   at least one download station, in communication with the        planning station, for downloading each of the work packages to        the primary capture tool associated with the corresponding user;        and    -   at least one upload station, for uploading the observations from        each of the primary capture tool.

Preferably, the user profile includes access and expertise levels of thecorresponding user. In this manner it is ensured that the observationsare collected by the right person in the right manner.

In one preferred embodiment, the present invention provides an atomicdata structure for use with the system and method mentioned above whichprevents the need for re-programming the database when migrating fromone observation task to another.

In another preferred embodiment, the system above further includes agraphical user interface which minimizes errors during the collection ofobservations. This is preferably achieved with a graphical userinterface for use with the primary capture tool to collect observationsof a target, the graphical user interface including a graphicalrepresentation of the target and a pick list. In practice the userselects a portion of the graphical representation of the target, uponwhich a pick list appears. This feature enables said primary capturetool to collect valid observations and measurements.

According to another aspect of the present invention, there is alsoprovided a method for a collection of observations by a plurality ofusers, this method including the steps of:

-   -   a) preparing work packages of observations to be collected by        the users, each work package being tailored to a user profile of        a corresponding user;    -   b) downloading each of the work packages to a primary capture        tool associated with the corresponding user;    -   c) having each of the users using the primary capture tool        associated therewith to collect observations according to the        work package downloaded thereto; and    -   d) uploading these observations from each of the primary capture        tools.

The present invention and its advantages will be more easily understoodupon reading the following non-restrictive description of preferredembodiments thereof, made with reference to the appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of a system for collectingobservations according to a preferred embodiment of the invention.

FIGS. 2 a and 2 b are schematic representations of the graphical userinterface in a reviewing mode according to one embodiment of theinvention; FIG. 2 a shows the interface prior to a findings review, andFIG. 2 b shows the interface after a findings review.

FIGS. 3 a and 3B are schematic representations of the graphical userinterface according to an embodiment of the invention, respectivelyshowing a dorsal (FIG. 3 a) and a ventral (FIG. 3 b) navigational viewof a target.

FIGS. 4 a, 4 b, 5 a and 5 b are other schematic representations of thegraphical user interface, showing a questionnaire. FIG. 4 a shows thequestionnaire as initially presented; FIG. 4 b shows it with themulti-select tool active; FIG. 5 a shows the same questionnairepartially answered and FIG. 5 b shows the same completed and signed.

FIG. 6 is a schematic representation of the architecture of a systemaccording to a preferred embodiment of the present invention.

FIG. 7 is a schematic representation of an atomic data structureaccording to a preferred embodiment of the invention.

DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION

Referring to FIG. 1, there is shown a physical implementation of asystem 10 for the collection of observations by a plurality of usersaccording to a preferred embodiment of the present invention. The system10 is preferably based on hand-held PCs and a traditional PCclient-server environment. The elements of the system 10 include:

-   -   a planning station 11;    -   at least one download station 13;    -   a plurality of primary capture tools 15;    -   at least one upload station 17; and    -   a data management database server (AtDB 19);

Each of these elements will be detailed hereinafter.

Planning Station

The planning station 11 is preferably a software-only package that isintended to run on any standard computer supporting a networkconnection. This station is used by a planning and scheduling group toprepare, based on the work plan, the various work packages (also calledJob Tickets) that are to be downloaded to the primary capture tools insupport of data collection activities. In the preferred embodiment, theplanning station 11 shares its information across the facility's localarea network (LAN) through a central database that interconnects allstations, except for the primary capture tool 15. The central databaseis also bridged to the Data Management database 19 through the variousstations and the facility's LAN or WAN communications (dial-up dedicatedservices or Internet access).

The planning station will allow the definition of an observationlexicon, associate a lexicon with an acquisition cycle (i.e. Time Pointand data collection task), prepare a list of authorized technicians(based on the training records and the task at hand) and establish thelist of test systems affected by the acquisition cycle. Work packagestailored to the user profile of each of the users making observationsare prepared based on this information, and preferably include anobservation procedure (which includes the lexicon), and supportinformation such as technical manuals, standard procedures, toolingset-up, previous observations, current observation subject configurationand allowed replacement parts.

The user profile includes any information relevant to each particularuser's ability to carry on observations. It may include a user accesslevel according to any appropriate authorization system, and anexpertise level of the user with respect to the inspection to beperformed. Consequently, the tailoring of the work packages ensures thatany observation is only carried out by personnel having the necessaryqualifications.

Download Station

The system also includes at least one download station 13, againpreferably embodied by a software package running on a standardcomputer, which is equipped with a docking port for the primary capturetool. Of course, any number of download stations 13 may be provided on agiven system depending on the needs of a particular application. Inpractice, a user first logs in and goes through an authenticationprocedure on a download station. Access to the system may be passwordprotected and a public/private key system is preferably used to ensurethe security of all transactions on the network. The user then makes aselection from a list of available tasks prepared for the currentacquisition cycle on the specified inspection task. With the primarycapture tool docked, a work package including the required information,such as authorized users, a list of test systems and previousacquisition cycle values, etc is transferred from the network to theprimary capture tool's own on-board database. Once the download iscomplete, the user logs off the download station and proceeds to acquireobservation data, for example in a clinic or investigator's office,through the now offline primary capture tool.

Primary Capture Tools

Each user is provided with a primary capture tool on which to record hisobservations. It preferably consists of a handheld computer device suchas a tablet computer running a windowing style operating system andproprietary software. Of course, different types of capture tools may beused within a same system. While each observation and or measurementtask which can be accomplished with the present invention requiresspecific-to-task software modules, the primary capture tool also offerssome across-the-board functions. In one exemplary embodiment, for theclinical trials market, these standard functions include:

-   -   a digital signature module allowing the Investigator-of-record        to review and confirm the content of the Case Report Form and,        through encryption techniques, apply a digital signature to the        document and force future changes to be audited. Any future        change will automatically remove the investigator's signature;    -   an automatic audit trail module that captures the time and        nature of any change to any committed observation or measurement        as well as the ID of the user making the change and a reason for        the change. The audit trail will also capture the action that        caused the data record to be modified; and    -   a standardized set of capture tools that can be tailored,        through data definitions, to support most Clinical Trial        requirements. Custom capture tools are possible but usually        unnecessary. The use of standard tools significantly reduces the        preparation time needed to field the acquisition units.

The use of hand-held or tablet PCs as the primary capture tool is highlyadvantageous over known prior art systems, for example in the field ofclinical trials in the pharmaceutical industry. It eliminates the needfor tethered operation of the capture computer in the examination room.In the pre-clinical setting, this un-tethered operation reduces thedanger of cross contamination of studies caused by the transfer ofcomputer carts from room to room. In the clinical setting, the size andmobility of the device make for greater acceptability by investigatorsgiven the limited space in which they operate. In aircraft inspections,the un-tethered operation means that the data capture tool can be usedas the only collection device even deep within the aircraft's structurewhere outside radio frequency signals are blocked.

The weight advantage the hardware has over a laptop is considerable (aslittle as 250 g vs. 6 to 8 kg). This weight advantage translates intoincreased user acceptance given that the technician or investigatortypically carries the device on his/her person for a full shift (8hours).

Upload Station

One or more upload stations 17 are provided as the final link in thedata capture chain. Like the other LAN-based components of the system ofthe present invention, the upload station is preferably embodied by asoftware package that runs on a standard computer. Its primary functionis to recover the observations captured on the primary capture tool. Itmay optionally prepare the primary capture tool for its next capturecycle.

In the preferred embodiment, the user profile and work package are againvalidated upon login in at the upload station. The upload stationadditionally monitors the collected data for any data excursions, whichare defined as valid observations, made by the technician in the field,which have a value (i.e. temperature or pressure or colour etc.) beyondthe range of expected values for a given observation. For example, watercould be observed to boil at 95° C. rather than 100° C.; this value issurprising but possible if, for example, the water container was athigher elevation. In this case, the system would ask the observer toconfirm the actual value as correct before committing it to thedatabase. This greatly reduces the time required to deal without-of-range and unusual data queries while ensuring maximum integrityof the data collected and the collection process itself. Advantageously,these limits and expected values are not “hard coded” into the program;rather, the allowed values or anticipated ranges as well as anyconditional processing of the questionnaires based on the observation(i.e. If the answer to question 5 is 12 or greater then processquestionnaire 6 starting at question 105 otherwise go to question 6 inthe original questionnaire) are parameters that are included in thedownload of information that controls the observation cycle.

Once the uploaded data is cleared of any ambiguities, the upload stationwill affect the transfer of the data to the Data Management database andupdate the Job Ticket's status within the central database.

Database Server

In a preferred embodiment of the invention, the system preferablyincludes a data management database server 19, hosting a data managementdatabase.

Preferably, this data management database presents an “atomic” datastructure as explained below.

While the use of relational database technology in the storage andretrieval of information collected through manual and automated means isa generalized approach in most data processing environments, thistechnology inherently requires that the data being stored and retrievedbe modeled as to its type, size and inter-relationships (meta data). Byusing a data abstraction model that reduces the data elements to theirmost simple expression (hence the use of the term “atomic” in describingthe database), the need for modeling the data inter-relationships isremoved from the database environment and placed within the dataelements themselves. In effect, the traditional meta data is transformedinto data. This has a consequence that virtually any type of data can becaptured by the system of the present invention and stored within theAtDB without the need of programming. This adaptability allows thesystem of the present embodiment to be retargeted from industries suchas Drug Development to Aerospace to Financial Management and InsuranceClaims processing without the need to reprogram or modify the database.

The data management database therefore preferably includes the use of afixed data abstraction (see FIG. 7) that reduces any reading orobservation made with the system of the present invention to a series ofsingle element records that carry within them the rules for recreatingtheir association with other records. In other words, each observationcollected is divided into storage elements each containing a singleinformation, including pointers linking associated storage elements forreconstructing the original observations.

This obviates the need for the database management system to understandthe nature of the information stored within it and, as a result, rendersthe database generic. Since the generic database does not need to beprogrammed, the system of the present invention can be tailored to aspecific capture activity more rapidly by users than other systems thatrely on programming resources to convert the data relationships intorelational structures through data modeling techniques.

FIG. 7 presents an example of a physical implementation of the databasewithin Microsoft Corporation's ADO™ data management environment. Theelements include:

-   -   Parameter table 201;    -   TimePoints table 203;    -   Readings table 205;    -   TextValue table 207;    -   NumericValue table 209;    -   WholeValue table 211;    -   DateTimeValue table 213; and    -   FileValue table 215.

The Parameter table 201 provides a User-specified name (ParameterName)for each data element stored in the Readings table along with thenecessary typing (ParameterValueType) to allow the system to correctlyselect the appropriate storage table.

For those cases where the information collected by the system isrepetitive (e.g. similar data collected on repeat visits to a clinicianor data collected at every preventative maintenance inspection of anaircraft), the TimePoints table is provided to allow the user to assigna name (TimePointTitle) and a schedule (ScheduleStart) to eachoccurrence of the data capture event.

The Readings table 205 holds all the information associated to a dataelement save for the actual value of the specific element. Given thatthe storage element is, in all cases, specific to the nature of theinformation held (i.e. picture, floating point number, integer value,text string), the readings table holds a pointer to the specific storageelement (ParameterID) as well as a type indicator (ParameterTypeID) usedto specify the storage element type.

The Readings table 205 holds an index to the TimePoints table 203(TimePointID), which allows similar data elements(ParameterID|ParameterTypeID) to be differentiated on an occurrencebasis.

The Readings table 205 maintains, through the use of pointer fields(RelatedParentID and RelatedChildID), the linkages necessary toreconstruct the associations between itself and other Readings records.These fields hold, as data, the information normally understood to bethe database's meta data. The fields form a linked list.

The Readings table 205 maintains information relating to the identity ofthe person making the observation (OperatorID), the time at which theobservation was made (TimeStamp) and the manner in which the observationwas made (InputMethod) as part of the data management and securitysystem.

Each of the data element tables (i.e. TextValue 207, NumericValue 209,WholeValue 211, DateTimeValue 213 and FileValue table 215) is structuredsimilarly in that they have an identifier field (ValueID) which servesto uniquely identify the value held and which is copied to the Readingstable's ValueID field, a value field (Value) which holds the dataelement's value and a status field (Status) used by the system todetermine the phase within the capture process each record is incurrently. The Value field is typed according to the data element typeit holds.

Of course, the structure above is given as an example only and is in noway limitative to the scope of the present invention.

The implementation of a generic or atomic data structure within theprimary data store eliminates the need to program a unique structure andcapture software for each study. The “atomic” nature of the data storeis derived from the fact that the relationship between data elements(meta data) normally held in the table structure of relational databasesis converted to data within the AtDB and is held there in exactly thesame fashion as the information data. This transformation allows theAtDB to hold virtually any type of measurement or observation withoutthe need of specific to purpose programming.

One skilled in the art will readily understand that while the varioussubsystems of the system of the present invention have been presented asinterconnected applications running from separate machines, theimplementation need not be thus. In fact, it is possible to run all theLAN/WAN based functions from a single machine to which the primarycapture tool's docking station is connected. Conversely, the functionscan be run through wide area technologies such as dial-up networks andthe Internet. The topology of any given implementation is more a matterof overall size of the operation and effective use of resources than anyparticular constraints associated with the system's design.

The system of the present invention is a data capture system and as suchrelies on the commercial Data Management System to which it isinterfaced to provide tabulation and reporting features. A companionproduct to the system with which it is fully integrated and from whichobservations and measurements can be tabulated is also contemplated.

METHOD ACCORDING TO A PREFERRED EMBODIMENT

The present invention further provides a method for the collection ofobservations by a plurality of users. The method includes the followingsteps:

-   -   a) preparing work packages of observations to be collected by        said users, each work package being tailored to a user profile        of a corresponding user. The user profile preferably includes        access and expertise levels of the user;    -   b) downloading each of said work packages to a primary capture        tool associated with the corresponding user;    -   c) having each of said users using the primary capture tool        associated therewith to collect observations according to the        work package downloaded thereto; and    -   d) uploading said observations from each of said primary capture        tool.

EXEMPLARY EMBODIMENT

An example of implementation of the present invention as applied toclinical trials will now be given in more details with reference to theappended drawings.

The OCP supports the definition, acquisition and transfer of Case ReportForm data. This data will include clinical observations made by theinvestigator as well as basic physical parameters and vital signs witheither user input or direct connection to electronic instruments.

The OCP will also address particular study needs with enhanced sensorconnectivity allowing for the direct connection of low-level sensorssuch as temperature, pressure, ECG and EKG, always maintaining the datacapture focus of the system.

In use, a user will initiate an observation cycle by logging on to theDownload Station and, after authentication, transfer, from the AtDB, therequired Protocol and associated data elements. Once the transfer iscomplete, the observation cycle is accomplished stand-alone without anyfurther support from the general computing environment, including thenetwork. The observation cycle will be closed with the transfer of theobservations from the primary capture tool to the holding database whichis designed to accept AtDB style data records. Each transfer willtrigger a verification and AtDB load cycle through the use of the UploadStation. In operation, the architecture will support, through programmedexecution, the collection of observations and measurements.

It is intended that all observations and measurements be capturedthrough the use of programmed user interactions with the primary capturetool. However in order to provide the flexibility required to quicklyadapt to client requests for peculiar data captures and one time onlydata captures, the architecture of the present invention will alsosupport the input of observations through the use of double entry formsand an interface called XLIF.

Reference will be now be made to FIG. 6, where the functionalarchitecture of the system of the present invention, the <<transferdata>> function provides all necessary bi-directional interfaces betweenthe User and the system. These interfaces include: User and Assignmentauthentication, Protocol data transfer, Associated data transfer,observations transfer, rules and glossary transfers. <<Captureobservations>> provides the necessary User interface to supportobservation cycle specific capture of human observations driven byobservation cycle specific glossaries and protocol requirements.<<Capture measurements>> (primary capture tool) will, under similarconstraints to <<capture observations>>, collects measurements directlyfrom electronic instruments connected via special-to-purpose interfacecards. <<Correlate observations>> and <<Analyse incidences>> representbasic analyses that might be carried out concurrently (primary capturetool) within the observation cycle on the same computer or once theobservation cycle is completed (Upload Station) and using a differentcomputer. The <<Maintain glossaries>> (Planning Station) is a functionthat allows the User to add, modify and/or delete, under the constraintsof applicable regulations, the vocabulary used to describe theobservations made in the course of an observation cycle. Finally, the<<Planning>> function (Planning Station) allows the user to derive jobtickets (data collection tasks) from the production planning system.

The system according to the present invention is a highly portablehardware/software system specifically designed to meet the needs oftechnical staff involved in the collection of data in closely regulatedindustries such as drug development and air transport services to thepublic.

While these markets are supported by existing data management systems,the system is according to the Applicant, unique in its focus on theacquisition portion of the data management process. This narrow focusallows the system to benefit from single purpose optimizations that areimpractical in larger multi-function implementations.

Once collected, the data can be transferred to any of the popular datamanagement systems currently on the market. In the case of ClinicalTrials, this means any SQL-92 compliant database manager or SASsolution. By providing specific gateways to commercial data managementsystems, the system of the present invention makes it possible for theend user community to improve their data capture quality and efficiencywithout incurring the time and expense associated with acquisition,training and validation of an entirely new system. Rather the validationburden is limited to the confirmation of acquired measurements andobservations and the training, which is directed at the technical staffand is highly visual with direct programmatic support for industry “bestpractices”.

The use of traditional (e.g. Windows®) graphical user interfaces (GUI)within the data capture environment is not new, nor is the use ofspecific graphical presentations for navigation of the capture process.The system's GUI shown in FIGS. 2 a, 2 b, 3 a, 3 b, 4 a, 4 b, 5 a, 5 bis however novel in that it uses the presentation of drawings coupled tospecialized software capture “tools” as its exclusive interface to theuser. This approach is critical to the architecture's goal ofsimplifying, streamlining and improving the overall effectiveness of theprocess automation provided by the system.

In the context of a clinical trial, the GUI include as elements:

The use of two sided (ventral and dorsal) images to provide localizationand lexical validation of each observation made (cf. FIG. 3). Thiscontributes both to the quality (accuracy) of the observation and theintuitiveness of the system. In the drug research setting, thistwo-sided presentation ensures that simple mistakes such aslateralization (confusing left with right or vice-versa) and use ofabdominal finding codes for chest observations are eliminated. In thelarge equipment maintenance setting, assembly drawings at multiplelevels of detail ensure that the correct item is being inspected andboth measured and observed using the correct tools. This is expected toreduce the incidences of incorrect part substitutions and inappropriatemaintenance actions due to poor training or recent changes toprocedures.

By limiting the user's opportunities for error (through the use of picklists and visual localization), subsequent revisions of the captureddata can focus on the analysis and interpretation of the findings ratherthan substantial quality reviews aimed at confirming that the correctcapture protocols, procedures and tools were used. In the drugdevelopment application this could reduce data review from three monthsto two days in the case of most mid-sized studies (studies with anaverage duration of 6 to 12 weeks).

At an operational level, the use of Test System schematics andapplication-specific lexicons force the capture operators to provideonly “valid” observations and measurements. The required metainformation (e.g. date/time stamp of captured data, ID of technician andinstrument used to capture data as well as confirmation that thetechnician performing the operation is currently qualified) is allintegrally associated to the data record by the OCP. This has importantimplications for both the quality of the data captured as well as theoverall cost of executing studies given that data verification andcorrection times are drastically reduced over traditional capturemethods.

The OCP functions in one of two basic modes with respect to its GraphicUser Interface. FIGS. 3 and 4 present the “specialized tool” mode, whichincorporates the two-sided graphic that was previously described. Thismode is considered a specialized mode as each implementation must beconfigured to operate with its graphics. FIG. 2 presents the “findingsreview” function of the “specialized tool” mode. This function tabulatesthe findings collected in the previous observation cycle. The user isrequired to review each finding and record whether it is present andunchanged 101, present and changed 103 or not found 105. Reviewedfindings are highlighted (shaded in FIG. 2 b). When all findings for aTest System have been reviewed, the review function re-labels thesecommand buttons (101, 103, 105) to allow the user to record newobservations.

FIGS. 2 and 3 present the “new findings” editor which incorporates thetwo-sided graphic presentation. With this function enabled, newobservations are recorded by tapping the graphic in the area thatlocalizes the site of the finding on the Test System. This actioninvokes a site specific list of detailed locations from which the useris to select. Once the detailed site is selected, a dialogue toolappears and guides the user through the selection of a finding andappropriate modifiers. The level of detail associated with eachobservation is established at the time an observation lexicon is defined(using the Planning Station). This detail is particular to each findingfor each detailed site of each location.

Beyond the essential collection presentation, the “specialized tool”mode includes a number of support controls:

-   -   The Test System selector 107 allows the user to navigate among        the pre-set list of Test Systems required to be observed in this        cycle. The selector includes controls to select the Next Test        System or the Previous Test System. Test Systems can be randomly        selected by tapping the current Test System field and selecting        from the pull-down list that is presented;    -   A set of three controls 109, 101, 113 are used to define the        specific type of observation being made (i.e. location        independent observation, location dependant observation and edit        tapped observation respectively);    -   The Critical Observation tool 115 allows the user to capture        critical observations related to Test Systems that are not        currently in the Test System selector list; and    -   The User Swap 117 which allows the user-of-record to be changed        in the field.

FIGS. 4 and 5 present the Questionnaire Processor mode of the system ofthe present invention.

This mode is considered the base mode of operation of the system as itrequires no “special to task” programming (assuming the required capturetools exists) and can be configured for operation by the users. As itsname implies, this mode uses a questionnaire metaphor (i.e. series ofquestions and answers on a linear form) to guide the user throughobservations. Each question posed (as presented in FIG. 4) hasassociated with it a capture tool that is configured with the list ofallowable answers. In operation, the user taps the question and ispresented with a capture tool (in FIG. 4, the user tapping the word“Gender” would result in the multi-select tool displaying the options“Male” and “Female”) from which he would make his selection.

Capture tools allowing dates, times, numeric values, comments andselection from lists are all presently included in the QuestionnaireProcessor. As specific instrument interfaces are developed, tools willbe programmed and included in the Questionnaire Processor. As with the“findings review” function, highlighting (shading in the drawings) isused to signify that a questionnaire is complete and has beenelectronically signed by the investigator-of-record.

Peripheral controls for this view include:

-   -   The Test System selector 119, 121, 123 which identifies the Test        System to which the answers of the questionnaire apply.        Navigation among the allowed Test Systems is achieved by tapping        the ellipsis button 119 and selecting a Test System from the        list presented;    -   The New TS control 125 allows the user to add a Test System to        his list of allowed Test Systems. The availability of this        control is determined by the user at the time the form is        configured in the Planning Station. Once in the field, the        function cannot be independently enabled or disabled;    -   The Sign control 127 is used by the investigator-of-record to        mark the answers collected against a Test System as reviewed and        set. Further changes made to these records will be administered        by the system's change control system (Audit Trail);    -   The User Swap 117 which allows the user-of-record to be changed        in the field.

Although the present invention has been explained hereinabove by way ofa preferred embodiment thereof, it should be pointed out that anymodifications to this preferred embodiment within the scope of theappended claims is not deemed to alter or change the nature and scope ofthe present invention.

1. A system for a collection of observations by a plurality of users,said system comprising: a planning station for preparing work packagesof observations to be collected by said users, each work package beingtailored to a user profile of a corresponding user; a plurality ofprimary capture tools, each associated with one of said users, each ofsaid primary capture tools being adapted to be used to collectobservations according to one of said work packages; at least onedownload station, in communication with said planning station, fordownloading each of said work packages to the primary capture toolassociated with the corresponding user; and at least one upload station,for uploading said observations from each of said primary capture tool.2. A system according to claim 1, wherein each user profile comprises anaccess level of said corresponding user.
 3. A system according to claim1, wherein each user profile comprises an expertise level of saidcorresponding user.
 4. A system according to claim 1, wherein each ofsaid work packages comprises an observation procedure, said observationprocedure including a lexicon.
 5. A system according to claim 4, whereineach of said work packages further comprise support information.
 6. Asystem according to claim 5, wherein said support information comprisesat least one element selected from the group comprising technicalmanuals, standard procedures, tooling set-ups, previous observations,current observation subject configurations and allowed replacementparts.
 7. A system according to claim 1, wherein each of said at leastone download station comprises authenticating means for authenticatingan identity of said users.
 8. A system according to claim 7, whereinsaid authenticating means comprise a password protection.
 9. A systemaccording to claim 1, wherein each of said primary capture tools is ahand-held device operating autonomously.
 10. A system according to claim9, wherein each of said primary capture tools is provided with agraphical user interface, said graphical user interface enabling thecapture of said observations.
 11. A system according to claim 10,wherein said graphical user interface includes an image of a target forwhich observations are being collected and a pick list, so that when aportion of the image of the target is selected by a user, said pick listnarrows the options available to the user to enter as an observation.12. A system according to claim 11, wherein said pick list isestablished according to an application specific lexicon.
 13. A systemaccording to claim 1, wherein said system further comprises a databaseserver including a data management database, said database server beingin communication with said upload station for receiving saidobservations therefrom.
 14. A system according to claim 13, wherein saiddata management database includes an atomic data structure wherein eachof said observations is divided into storage elements each containing asingle information.
 15. A system according to claim 14, wherein saidstorage elements comprise pointers linking associated data elements forreconstructing said observations.
 16. A method for a collection ofobservations by a plurality of users, said method comprising the stepsof: a) preparing work packages of observations to be collected by saidusers, each work package being tailored to a user profile of acorresponding user; b) downloading each of said work packages to aprimary capture tool associated with the corresponding user; c) havingeach of said users using the primary capture tool associated therewithto collect observations according to the work package downloadedthereto; and d) uploading said observations from each of said primarycapture tool.
 17. A method according to claim 16, wherein each userprofile comprises an access level of said corresponding user.
 18. Amethod according to claim 16, wherein each user profile comprises anexpertise level of said corresponding user.